Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020205
Company: TARO PHARMS NORTH
Company: TARO PHARMS NORTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PSORCON | DIFLORASONE DIACETATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/20/1992 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/30/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/10/1997 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |